Psychiatr News November 3, 2006
Volume 41, Number 21, page 23
© 2006 American Psychiatric Association
Study Questions Superiority Of Newer Antipsychotics
Jim Rosack
The researchers' hypothesis that SGAs would have a substantial advantage
over FGAs in patients' quality of life didn't pan out.
Research funded by the United Kingdom's National Health Service suggests
that when patients with schizophrenia need to change their medication, either
because of ineffectiveness or intolerable side effects, the newer,
nonclozapine second-generation antipsychotics (SGAs) do not appear to offer
significant benefits over the first-generation antipsychotics (FGAs).
The study's findings, reported in the October Archives of General
Psychiatry, have generated significant discussion (see article
below).
The study, known as the Cost Utility of the Latest Antipsychotic Drugs in
Schizophrenia Study (CUtLASS 1), is the second over the last year to challenge
the widely held perception that SGAs are safer and more effective in treating
patients with schizophrenia than are the FGAs. In April, results from the
National Institute of Mental Health's CATIE (Clinical Antipsychotic Trials of
Intervention Effectiveness) study indicated that in general patients were
likely to do as well on the FGA perphenazine as on newer SGAs (Psychiatric
News, April 21).
For nearly 50 years, patients taking the older medications would often
relapse or develop severe side effects, including sedation and involuntary
muscle movements. The development of SGAs was thought to be a major advance
primarily because the medications reduced the risk of extrapyramidal symptoms
and the potential for development of tardive dyskinesia over the long term.
Claims that the SGAs are more effective than the FGAs resulted in significant
shifting of prescribing patterns away from the older drugs, even though
research comparing the old and the new has produced mixed results.
In the Archives report, Peter Jones, M.D., Ph.D., a professor of
psychiatry at the University of Cambridge and Cambridgeshire and Peterborough
Mental Health NHS Trust, and colleagues studied 227 people with schizophrenia
aged 18 to 65 from 14 community psychiatric services in the English National
Health Service.
"The key question was whether the additional acquisition costs of
second-generation antipsychotics over first-generation antipsychotics would be
offset by improvements in health-related quality of life or savings in the use
of other health and social care services in people with schizophrenia for whom
a change in drug treatment was being considered for clinical reasons, most
commonly suboptimal efficacy or adverse effects," Jones and his
coauthors wrote.
The participants were randomly assigned to receive one class of drug or the
other. (Clozapine was not included in the study; see
box) However, their
treating physicians determined which of the first- or second-generation
medications would be best for them. In the FGA group, 49.15 percent of the
patients were started on sulpiride, which is not available in the United
States. In the SGA group, 46 percent were started on olanzapine.
Participants were assessed at baseline and at 12, 26, and 52 weeks after
the change in treatment with the Quality of Life Scale, where higher scores
reflect a better quality of life.
The researchers hypothesized that the SGAs would produce a five-point
improvement in quality-of-life scores compared with the FGAs. Symptoms, side
effects, treatment costs, and satisfaction with the drug also were
measured.
The researchers expressed surprise in finding their hypothesis was not
validated (see chart).
"Participants in the first-generation antipsychotic arm showed a
trend toward greater improvements in Quality of Life Scale and symptom
scores," the authors noted. "Participants reported no clear
preference for either drug group; and lastly, costs were similar."
Over the course of the 52 weeks of the trial, mean total costs per patient
in the FGA arm were $34,750, compared with $37,185 per patient in the SGA arm.
Antipsychotic drug costs accounted for only a small portion of the total costs
encountered (2.1 percent for FGAs, and 3.8 percent for SGAs). There was a
greater difference in hospitalization costs: inpatient admissions accounted
for 93.2 percent of total costs in the FGA arm and 81.5 percent in the SGA
arm. Overall the authors concluded that costs were similar between the FGA and
SGA arms though they noted that there was a trend toward greater costs in the
SGA arm.
"All the data suggest that careful prescribing of first-generation
antipsychotics, at least in the context of a trial, is not associated with
poorer efficacy or a greater adverse-effect burden, both of which would
translate into lower quality of life in the medium term," Jones and his
coauthors concluded. "This suggests that despite recent policy
statements and prescribing patterns, further randomized and other evaluations
of second-generation antipsychotics would still be useful in establishing
their role in the long-term management of schizophrenia and, likewise, the
continued role of older drugs."
An abstract of "Randomized Controlled Trial of the Effect on
Quality of Life of Second- vs. First-Generation Antipsychotic Drugs in
Schizophrenia" is posted at
<http://archpsyc.ama-assn.org/cgi/content/full/63/10/1079>.
Related Article:
-
Medications Included in Study
Psychiatr News 2006 41: 23.
[Full Text]
This article has been cited by other articles:
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R.A. Rosenheck, D.L. Leslie, S. Busch, E. S. Rofman, and M. Sernyak
Rethinking Antipsychotic Formulary Policy
Schizophr Bull,
March 1, 2008;
34(2):
375 - 380.
[Abstract]
[Full Text]
[PDF]
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